New Terminology Old Problem! Dr. Chevelta A. Smith Adjunct Professor of LECOM - OB/Gyn March 3, 2018 Discuss the reason behind the development of this new terminology Review the Old Terminology for which Genitourinary Syndrome of Menopause (GSM) is replacing Outline a Primary Care physician (PCP) approach to GSM Assist the PCP in recognizing the clinical presentation of GSM Explore the step wise treatment options for GSM Empower the PCP to feel comfortable with initiating treatment for GSM 1
Taboo Words? or Are They? clitoris ORIGINAL TERMS: So Why The Need to Change? Vulvovaginal Atrophy is a term which describes a clinical appearance but does not include symptoms. General public uncomfortable with using word vagina or vaginal Who Changed It?... 2
...AND WHY!? OBJECTIVES 3-FOLD 1. To review the basic and clinical science related to the genitourinary physical changes and resultant symptoms associated with menopause, & to identify key elements relevant to the terminology 2. To determine whether the term vulvovaginal atrophy should be revised and, if so, to develop a new term that more accurately and appropriately describes the condition for medical care, teaching and research 3. To generate a plan for disseminating recommendations and raising awareness of the new terminology among members of the broader health care community, including specialist, PCPs, researchers, and patients, as well as the public PROCESS 5 person selection committee chose experts from the field of postmenopausal urogenital and sexual healthy fields. Chosen experts invited to attend a 2 day interdisciplinary consensus conference Experts evaluated the current terminology for symptomatic urogenital changes associated with menopause Upon completion of literature review, experts determined that a change in terminology was needed to: Be more acceptable to women, educators, researchers, public, and media Exploration of terms that would be descriptive, comprehensive, and suitable for all 3
Conclusion of Consensus Conference Final two proposed new terms where presented for an open discussion at 2 scientific meetings: Annual Meeting of NAMS October 2013 Annual Meeting of ISSWSH February 2014 Conclusion of Scientific Meetings New Terminology Approved: 4
GENITOURINARY SYNDROME OF MENOPAUSE Chronic, progressive vulvovaginal, sexual, and lower urinary tract condition... Involves multiple symptoms Due to hypoestrogenism secondary to the menopausal state > 50% of postmenopausal women affected External Genitalia Urological Sexual 5
Embryonic Development: Urogenital sinus Mullerian duct = uterus and upper 4/5 of vagina once fused Sinovaginal node (Muller tubercle) Vaginal vestibule, and lower 1/5 of the vagina, urinary bladder, trigone, and urethra formed by all the above. Due to hypoestrogenic state 6
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YOU GOT TO ASK! LOOK Inspect the external genitalia Mons pubis Clitoris Labia majora & minora Urethra meatus Vestibule Introitus Inspect the internal genitalia Vaginal walls Cervix 10
TALK Discuss your findings:* Patient focused Care-giver focused Patient & Care-giver focused Explain what your findings mean:* Clinically (Diagnosis/Treatmemt0 Personally (for the patient) *Physician comfort and confidence important DO Take Action Expectant management Conservative treatment Medication administration Refer Gynecologist Physical Therapist Oncologist 11
Y o u C a n D o I t Laser/ Vaginal DHEA* Ospemifene Low Dose Vaginal Estrogen Mechanical Measures Long Acting Vaginal Moisturizers Nonhormonal Vaginal Lubricants 5 4 3 2 Determine Severity of Symptoms 1 12
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VAGINAL ESTROGEN BLACK BOX WARNING On all estrogen classed medications, including HT No distinction between route No distinction between dose Warning based on WHI trial & other studies specific to systemic ET or EPT Study findings not relevant to low dose vaginal estrogen Minimal if any systemic absorption Low PM blood estradiol levels compared to systemic estrogen VAGINAL ESTROGEN BLACK BOX WARNING Observation studies and short term RCTs for low dose vaginal estrogen demonstrate: No evidence of increased VTE risks, breast cancer, stroke, heart disease, or dementia Current box warning is inappropriate and based on extrapolated results from systemic MHT Health care providers and patients deterred from using, based on findings VAGINAL ESTROGEN BLACK BOX REVISION RECOMMENDED!!! 14
A citizen s petition filed in 2016 600 signatures clinicians, patients, medical & professional organization representatives FDA reconfirmed that ALL estrogen products will have black box warning 15
Oral treatment for vulvovaginal atrophy and dyspareunia Innovative treatment option for GSM 16
Discuss the reason behind the development of this new terminology Review the Old Terminology for which Genitourinary Syndrome of Menopause (GSM) is replacing Outline a Primary Care physician (PCP) approach to GSM Assist the PCP in recognizing the clinical presentation of GSM Explore the step wise treatment options for GSM Empower the PCP to feel comfortable with initiating treatment for GSM MENOPRO NAMS APP 17
drchevelta.com THANK YOU! 18